BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MICRO CATHETERS

    MDR report key: 4841418 · Received June 12, 2015

    Report

    Report Number
    2029214-2015-00651
    Event Type
    Injury
    Date Received
    June 12, 2015
    Date of Event
    August 1, 2009
    Report Date
    May 14, 2015
    Manufacturer
    IRVINE
    Product Code
    KRA
    PMA / PMN Number
    K093750
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HTTP://WWW.NCBI.NLM.NIH.GOV/PUBMED/19625907. THIS REPORT WAS CREATED TO CAPTURE THE SERIOUS INJURIES RELATED TO THE UNKNOWN MICROCATHETER. THE CATHETER WAS NOT RETURNED FOR ANALYSIS; THEREFORE, THE EVENT CAUSE COULD NOT BE DETERMINED. THE LOT HISTORY RECORD REVIEW WAS NOT POSSIBLE SINCE THE LOT NUMBERS WERE NOT REPORTED. NOTE: PER THE ONYX IFU (INSTRUCTION FOR USE): DO NOT ALLOW MORE THAN 1 CM OF ONYX TO REFLUX BACK OVER CATHETER TIP. EXCESSIVE ONYX REFLUX RESULT IN DIFFICULT CATHETER REMOVAL AND POTENTIAL ENTRAPMENT. (B)(4). INFORMATION RECEIVED FROM THE SAME ARTICLE AS MFR: 2029214-2015-00650.

    Description of Event or Problem · 1

    CITATION: QUINGAI HUANG. USE OF ONYX IN THE MANAGEMENT OF TENTORIAL DURAL ARTERIOVENOUS FISTULE.NEUROSURGERY. 2009 AUG;65(2):287-92; DISCUSSION 292-3. DOI: 10.1227/01.NEU.0000348298.75128.D0. THE FOLLOWING REPORT WAS RECEIVED BY MEDTRONIC (COVIDIEN) THROUGH REVIEW OF LITERATURE: ONE PATIENT HAD MICROCATHETER RETENTION. THE FEEDING ARTERIES IN THIS PATIENT INCLUDED THE RIGHT TENTORIAL ARTERY BRANCHES OF THE LEFT OCCIPITAL ARTERY AND THE ASCENDING PHARYNGEAL ARTERY AND THE LEFT SUPERIOR CEREBELLAR ARTERY. THE LENGTHENED, SMALL AND TORTUOUS PATHWAY FROM THE THREE FORMER FEEDING ARTERIES MADE MICROCATHETER CANNULATION DIFFICULT. THE CATHETER WAS EASILY POSITIONED THROUGH THE SUPERIOR CEREBELLAR ARTERY INTO THE FISTULA. ONYX 18 WAS INJECTED FOR 25 MINUTES, AND THE FISTULA WAS TOTALLY OCCLUDED. ONYX REFLUX WAS LONGER THE 2.5 CM, WHICH RESULTED IN RETENTION OF MICROCATHETER. THE PATIENT WAS GIVEN A DAILY DOSE OF 100 MG OF ASPIRIN ORALLY FOR 3 MONTHS. THE PATIENT RECOVERED WELL WITH NEUROLOGICAL INTACT. A TOTAL OF 16 PATIENTS PRESENTED WITH TENTORIAL DURAL FISTULAE. OF THESE, 14 PATIENTS, WERE TREATED WITH TRANSARTERIAL EMBOLIZATION (13 MEN AND 1 WOMAN). THE PATIENTS AGES RANGED FROM 37-65 (MEAN AGE, 50 YEARS). ULTRAFLOW OR MARATHON MICROCATHETERS WERE USED IN THE PROCEDURES. IT IS UNKNOWN WHICH OF THE TWO WERE USED IN THIS PARTICULAR CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386548 UNKNOWN MICRO CATHETERS CATHETER, CONTINUOUS FLUSH KRA IRVINE

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Disability